Class 3 Device Recall CXM 30

• Date Initiated by Firm: December 05, 2002
• Date Posted: March 06, 2003
• Recall Status: Terminated on March 31, 2003
• Recall Number: Z-0613-03
• Recall Event ID: 25250
• Product Classification: Susceptibility Test Discs, Antimicrobial - Product Code JTN
• Product: REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.
• Code Information: Lot Number: 254243 - Exp. 09/04
• FEI Number: 1924669
• Recalling Firm/ Manufacturer: Remel, Inc.; 12076 Santa Fe Dr; Lenexa KS 66215
• Manufacturer Reason for Recall: Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.
• FDA Determined Cause: Other
• Action: Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer.
• Quantity in Commerce: 104 Pkg
• Distribution: The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.